Home / Recalls / GE OEC Medical Systems, Inc / Z-2276-2023

Z-2276-2023 Class II Ongoing

Recalled by GE OEC Medical Systems, Inc — Salt Lake City, UT

FDA device recall Z-2276-2023 was initiated by GE OEC Medical Systems, Inc on May 15, 2023 and is designated Class II. Reason for recall: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier … The recall status is ongoing. Affected quantity: 58.

Recall Details

Product Type: Devices
Report Date: August 9, 2023
Initiation Date: May 15, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 58

Product Description

OEC 9800 Systems with 9-inch Image Intensifier

Reason for Recall

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.

Code Information

UDI-DI: 00840682114349. Serial Numbers: 89-0317, 89-0554, 8S-1293, 8S-0509, 8S-0108, 8S-1029, 8S-2836, 89-3028, 8S-1574, 89-0609-RC, 89-1308, 8S-0394, 89-0979, 8SXXXX03626, 8SXXXX03683, 8SXXXX03681, 8S-1894, 8S-0175, 8S-2988, 89-2459, 89-2101, 89-3245, 89-1623, 89-0296, 8S-0200, 8S-0748, 89-1590, 89-1713, 8S-0124, 89-0282, 8S-2580, 89-3132, 8S-3039, 89-3451, 89-0223, 89-1155, 8SXXXX03680, 8S-3278, 8S-2426, 89-2913, 8S-1167, 89-1278, 89-1854, 8S-0233-C, 8S-1926, 8SXXXX03682, 89-2167, 8S-1109, 8SXXXX03679, 8S-0410, 89-1579-N, 89-1920, 89-3102, 8S-2046-C, 89-2340, 89-0461, 89-3809, 89-3810

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Z-0706-2025 Class II — OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series (November 21, 2024)
Z-0703-2025 Class II — OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D i (November 21, 2024)
Z-0705-2025 Class II — OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 99 (November 21, 2024)
Z-0704-2025 Class II — OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC E (November 21, 2024)
Z-2279-2023 Class II — Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, (May 15, 2023)
Z-2277-2023 Class II — OEC 9900 Systems with 9-inch Image Intensifier (May 15, 2023)
Z-2275-2023 Class II — OEC Flexiview 8800 Systems with 9-inch Image Intensifier (May 15, 2023)
Z-2278-2023 Class II — OEC Elite Systems with 9-inch Image Intensifier (May 15, 2023)
Z-2161-2021 Class II — OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and dig (June 10, 2021)
Z-2160-2021 Class II — OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Us (June 10, 2021)